Background/Objectives: Photoimmunotherapy for head and neck cancer (HN-PIT) is an emerging treatment for unresectable locally advanced or recurrent head and neck cancer. However, real-world data (RWD) are limited. This study examined the safety and effectiveness of HN-PIT. Methods: This multicenter, retrospective cohort study included 40 patients with unresectable locally advanced or recurrent head and neck cancers who underwent HN-PIT from January 2021 to August 2024. The primary endpoint was time to treatment failure (TTF). Secondary endpoints included the objective response rate (ORR), overall survival (OS), progression-free survival (PFS), and adverse events (AEs). Results: The median TTF and 1-year treatment failure rate were 6.0 months and 23.2%, respectively. Moreover, the ORR, disease control rate, median OS, and median PFS were 75.0% (95% confidence interval [CI]: 60.0–86.0%), 95.0% (95% CI: 83.5–99.0%), 26.9 months, and 6.2 months, respectively. The incidence of grade ≥3 AEs was 17.5% (95% CI: 7.1–29.1%). Pain was the most common AE, occurring in 37 patients (92.5%), with grade III pain reported in 5 (12.5%). Mucositis occurred in 32 patients (80.0%), with grade III mucositis reported in 3 (7.5%). Hemorrhages occurred in 31 patients (77.5%), with no grade ≥III hemorrhages reported. Two patients experienced sepsis (5.0%; grades IV and V). Seventeen patients (42.5%) had laryngeal edema, with grade IV edema reported in four (10.0%). Conclusions: Our RWD shows that HN-PIT is effective with an acceptable safety profile. TTF may serve as an endpoint reflecting this treatment’s characteristics. This study provides important basic data for the development of future treatment strategies.
背景/目的：头颈部肿瘤光免疫疗法（HN-PIT）是针对不可切除局部晚期或复发性头颈部肿瘤的新兴疗法，但目前真实世界数据有限。本研究旨在评估HN-PIT的安全性与有效性。方法：这项多中心回顾性队列研究纳入了2021年1月至2024年8月期间接受HN-PIT治疗的40例不可切除局部晚期或复发性头颈部肿瘤患者。主要终点为至治疗失败时间，次要终点包括客观缓解率、总生存期、无进展生存期及不良事件。结果：中位至治疗失败时间为6.0个月，1年治疗失败率为23.2%。客观缓解率为75.0%（95%置信区间：60.0–86.0%），疾病控制率为95.0%（95%置信区间：83.5–99.0%），中位总生存期为26.9个月，中位无进展生存期为6.2个月。≥3级不良事件发生率为17.5%（95%置信区间：7.1–29.1%）。疼痛是最常见不良事件（37例，92.5%），其中Ⅲ级疼痛5例（12.5%）；黏膜炎32例（80.0%），Ⅲ级黏膜炎3例（7.5%）；出血31例（77.5%），无≥Ⅲ级出血；脓毒症2例（5.0%，分别为Ⅳ级和Ⅴ级）；喉水肿17例（42.5%），其中Ⅳ级水肿4例（10.0%）。结论：真实世界数据表明HN-PIT疗效显著且安全性可接受。至治疗失败时间可作为反映该疗法特征的终点指标。本研究为未来治疗策略的制定提供了重要基础数据。
肿瘤(癌症)患者之家